Randomised trial of water-filtered infrared A (WIRA) warming during insertion of umbilical lines

ISRCTN	ISRCTN60384118
DOI	https://doi.org/10.1186/ISRCTN60384118
Secondary identifying numbers	N0453150119

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 14/09/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Simon Mitchell
Scientific

Central Manchester & Manchester Children's University Hospitals SMH
St Mary's Hospital for Women & Children
Oxford Road
Manchester
M13 0JH
United Kingdom

Phone	+44
Email	simon.mitchell@cmmc.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Randomised trial of water-filtered infrared A (WIRA) warming during insertion of umbilical lines
Study objectives	To determine whether a WIRA lamp in addition to a standard incubator is more effective than standard incubator alone in preventing extremely premature babies from getting cold during insertion of umbilical lines after admission to neonatal medical unit.
Ethics approval(s)	Central Manchester Research Ethics Committee, ref 04/Q1407/75, 15/07/2004.
Health condition(s) or problem(s) studied	Neonatal Diseases
Intervention	Infants will be allocated to conventional warming or conventional plus WIRA during admission/stabilisation by block randomisation.
Intervention type	Other
Primary outcome measure	Axillary temperature at completion of umbilical line insertion
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/09/2004
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target number of participants	44 infants
Key inclusion criteria	Infants below 28 weeks admitted to neonatal unit
Key exclusion criteria	1. Parental consent not obtained 2. Major congenital abnormality
Date of first enrolment	01/09/2004
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Central Manchester & Manchester Children's University Hospitals SMH

Manchester
M13 0JH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	pw96	30/09/2015		No	No

Editorial Notes

14/09/2017: internal review.